State specific objectives, including any prespecified hypotheses P.7; Line 136. â 139 ... 15. Report numbers of outcome events or summary measures. P.15 â16;.
STROBE Statement—Checklist of items Title and abstract
Item No 1
Pages Recommendation (a) Indicate the study’s design with a commonly used term in
Title : P.1;
the title or the abstract
Line 1-5
(b) Provide in the abstract an informative and balanced
Abstract : P.3
summary of what was done and what was found
– 4; Line 43 –72
Introduction Background/rationale Objectives
2 3
Explain the scientific background and rationale for the
P.5-7; Line
investigation being reported
76 – 135
State specific objectives, including any prespecified hypotheses
P.7; Line 136 – 139
Methods Study design
4
Present key elements of study design early in the paper
Setting
5
Describe the setting, locations, and relevant dates, including
P.9; Line 162
periods of recruitment, exposure, follow-up, and data collection
– 168.
P.7-8;Line 141 –146
P.9; Line 176 – 184. P.10; Line 189 – 196. Participants Variables
Data sources/
6 7
8
measurement Bias
9
(a) Give the eligibility criteria, and the sources and methods of
P.8; Line 147
selection of participants
–157
Clearly define all outcomes, exposures, predictors, potential
P.10 – 11;
confounders, and effect modifiers. Give diagnostic criteria, if
Line 212 –
applicable
217
For each variable of interest, give sources of data and details of
P.11 –12;
methods of assessment (measurement). Describe comparability
Line 228 –
of assessment methods if there is more than one group
254
Describe any efforts to address potential sources of bias
P.12; Line 245 – 249
Study size
10
Explain how the study size was arrived at
N/A
Quantitative variables
11
Explain how quantitative variables were handled in the
P.13; Line
analyses. If applicable, describe which groupings were chosen
270 – 272
and why Statistical methods
12
(a) Describe all statistical methods, including those used to
P.13; Line
control for confounding
272 – 278
(b) Describe any methods used to examine subgroups and
P.13; Line
interactions
273 – 274
(c) Explain how missing data were addressed
P.14; Line 279 – 280
(d) If applicable, describe analytical methods taking account of
N/A
sampling strategy (e) Describe any sensitivity analyses
P.13; Line 273 – 274
1
Results Participants
13
(a) Report numbers of individuals at each stage of study—eg
P.14; Line
numbers potentially eligible, examined for eligibility,
285 – 290
confirmed eligible, included in the study, completing followup, and analysed (b) Give reasons for non-participation at each stage
P.11; Line 230 – 231
(c) Consider use of a flow diagram
P.14; Line 291 – 296
Descriptive data
Outcome data
14
15
(a) Give characteristics of study participants (eg demographic,
P.14 –15;
clinical, social) and information on exposures and potential
Line 291–
confounders
299
(b) Indicate number of participants with missing data for each
P.14; Line
variable of interest
279 – 280
Report numbers of outcome events or summary measures
P.15 –16; Line 300 – 319 P.16 –17; Line 323 – 339 P.17–18; Line 340 – 355
Main results
16
(a) Give unadjusted estimates and, if applicable, confounder-
N/A
adjusted estimates and their precision (eg, 95% confidence interval). Make clear which confounders were adjusted for and why they were included (b) Report category boundaries when continuous variables were
N/A
categorized (c) If relevant, consider translating estimates of relative risk
N/A
into absolute risk for a meaningful time period Other analyses
17
Report other analyses done—eg analyses of subgroups and
N/A
interactions, and sensitivity analyses Discussion Key results
18
Summarise key results with reference to study objectives
P.16 – 19; Line 306-362
Limitations
Interpretation
Generalisability Other information Funding
19
20
21
22
Discuss limitations of the study, taking into account sources of
P.21 – 22;
potential bias or imprecision. Discuss both direction and
Line 415 –
magnitude of any potential bias
425
Give a cautious overall interpretation of results considering
P.19 – 21;
objectives, limitations, multiplicity of analyses, results from
Line 371 –
similar studies, and other relevant evidence
414
Discuss the generalisability (external validity) of the study
P.22; Line
results
431 – 434
Give the source of funding and the role of the funders for the
P.23; Line
present study and, if applicable, for the original study on which
447 – 449
2
the present article is based Note: An Explanation and Elaboration article discusses each checklist item and gives methodological background and published examples of transparent reporting. The STROBE checklist is best used in conjunction with this article (freely available on the Web sites of PLoS Medicine at http://www.plosmedicine.org/, Annals of Internal Medicine at http://www.annals.org/, and Epidemiology at http://www.epidem.com/). Information on the STROBE Initiative is available at www.strobe-statement.org.
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